Ireland
--:--IST
Active, not recruiting Observational

Descriptive Observational Study on the Characteristics of Advanced and Metastatic Melanoma in Spain

NCT03605771 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2018-08-07
Last updated
2026-09-17

Condition(s) studied

Melanoma Stage IvMelanoma Stage IiiAdvanced Cancer

Investigational drug(s) / intervention(s)

Daily Clinical Practice

Daily Clinical Practice: The assignment of a patient to a specific therapeutic strategy will not be decided in advance by the study protocol, but will be determined by the usual clinical practice of medicine, and the decision to prescribe a specific treatment will be clearly dissociated from the decision to include a patient in the study. No intervention will be applied to patients, either diagnostic or follow-up, other than the usual clinical practice.

Study summary

This is an observational, multicentre epidemiological study with a longitudinal cohort in which information will be retrieved from medical records of patients with advanced metastatic or unresectable melanoma at first diagnosis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients of legal age with stage III, metastatic, or unresectable melanoma at first diagnosis after January 8, 2018. First diagnosis is understood as: a. Disease onset as metastatic or unresectable disease; b. First metastatic or unresectable relapse in the pre-established dates (after January 8, 2018) in a patient with previous localised melanoma and completely resected on dates before the pre-inclusion period. * Signing the Informed Consent Form (ICF). * A patient may have received the first or subsequent treatments for metastatic or unresectable disease in a hospital other than the centre where the ICF was signed, as long as the patient meets the inclusion criteria 1. * A patient can only sign one ICF (cannot sign an ICF in two different centres). * If a patient signs the ICF in a centre during the first-line therapy and then goes to another centre with consideration for the following lines: If the centre is associated with the GEM-1801 study, researchers will do their best to update the following lines and the patient status, introducing the new information in the centre where the ICF was initially signed. This information will be provided by the patient before contacting the principal investigator and always with prior consent of the patient, who will have previously provided the consent to contact by telephone for this purpose. If this second (or subsequent) centre is not associated with the GEM- 1801 study, this will be considered loss of follow-up, unless the patient returns to the GEM-1801 start centre, wherein the reporting physicians will do their best to update the information from other centres, always with prior patient consent, who will have previously signed the ICF; c) A patient card with the assigned code will be delivered. Exclusion Criteria: * Any patient not complying with inclusion criteria.

Primary outcome measure(s)

  • Sample Characteristics — Baseline
    Sociodemographic and disease characteristics of patients diagnosed with stage III, metastatic or unresectable melanoma at first diagnosis.

Trial sites (39)

FacilityCityRegionStatus
Hospital Virgen de los Lirios Alcoy Alicante
Hospital Universitario Virgen de las Nieves Granada Andalusia
Onconogranada Granada Andalusia
Hospital Universitario Regional de Málaga Málaga Andalusia
Hospital Universitari Vall d'Hebron Barcelona Barcelona
Parc Taulí Sabadell Barcelona
Hospital Universitario Araba Txagorritxu Victoria Vitoria-Gasteiz Basque Country
Hospital Universitario Marqués de Valdecilla Santander Cantabria
Hospital Universitario de Burgos Burgos Castille and León
Complejo Asistencial Universitario de Salamanca Salamanca Castille and León
Hospital Universitario Río Hortega Valladolid Castille and León
Hospital General de Ciudad Real Ciudad Real Castille-La Mancha
Instituto Catalán de Oncología Badalona Badalona Catalonia
Hospital de la Santa Creu y Sant Pau Barcelona Catalonia
Hospital Universitario Quirón Dexeus Barcelona Catalonia
Hospital Universitario San Pedro Alcántara Cáceres Extremadura
Onkologikoa Donostia / San Sebastian Guipuzcoa
Hospital San Pedro Logroño La Rioja
Hospital Lucus Augusti Lugo Lugo
Hospital Universitario La Princesa Madrid Madrid
Hospital Universitario La Paz Madrid Madrid
Hospital Universitario Ramón y Cajal Madrid Madrid
Hospital Universitario Puerta de Hierro-Majadahonda Majadahonda Madrid
Hospital Clínico Universitario Virgen de la Arrixaca El Palmar Murcia
Hospital Costa del Sol Marbella Málaga
Complejo Hospitalario de Navarra Pamplona Navarre
Hospital Universitario Son Llàtzer Palma de Mallorca Palma
Complejo Hospitalario de Pontevedra Pontevedra Pontevedra
Hospital Universitario de Valme Seville Sevilla
Hospital Virgen de la Salud Toledo Toledo
Hospital La Ribera Alzira Valencia
Hospital General Universitario de Valencia Valencia Valencia
Instituto Valenciano de Oncología Valencia Valencia
Hospital Clínico Universitario de Valladolid Valladolid Valladolid
Hospital Universitario Miguel Servet Zaragoza Zaragoza
Hospital Clínico Universitario Lozano Blesa Zaragoza Zaragoza
Hospital Clínico San Carlos Madrid Spain
Hospital General Universitario Gregorio Marañón Madrid Spain
Clínica Universidad de Navarra Pamplona Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03605771 on ClinicalTrials.gov ↗ ← All trials in Spain